98-11271. Tebufenozide; Tolerance Extension for Emergency Exemptions

[Federal Register Volume 63, Number 82 (Wednesday, April 29, 1998)]
[Rules and Regulations]
[Pages 23390-23392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-11271]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

OPP-300641; FRL-5784-7]
RIN 2070-AB78


Tebufenozide; Tolerance Extension for Emergency Exemptions

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This rule extends a time-limited tolerance for residues of the 
insecticide tebufenozide in or on apples at 1.0 part per million (ppm); 
apple pomace at 2.0 ppm; milk at 0.05 ppm; cattle, sheep and goat meat 
at 0.02 ppm, fat at 0.10, kidney at 0.02 ppm, liver at 1.0 ppm and meat 
byproducts at 0.10 ppm; and horse meat at 0.02 ppm for an additional 18 
month period, to December 30, 1999. This action is in response to EPA's 
granting of an emergency exemption under section 18 of the Federal 
Insecticide, Fungicide, and Rodenticide Act authorizing use of the 
pesticide on apples. Section 408(l)(6) of the FFDCA requires EPA to 
establish a time-limited tolerance or exemption from the requirement 
for a tolerance for pesticide chemical residues in food that will 
result from the use of a pesticide under an emergency exemption granted 
by EPA under section 18 of FIFRA.

DATES: This regulation becomes effective April 29, 1998. Objections and 
requests for hearings must be received by EPA, on or before June 29, 
1998.
ADDRESSES: Written objections and hearing requests, identified by the 
docket control number, [OPP-300641], must be submitted to: Hearing 
Clerk (1900), Environmental Protection Agency, Rm. M3708, 401 M St., 
SW., Washington, DC 20460. Fees accompanying objections and hearing 
requests shall be labeled ``Tolerance Petition Fees'' and forwarded to: 
EPA Headquarters Accounting Operations Branch, OPP (Tolerance Fees), 
P.O. Box 360277M, Pittsburgh, PA 15251. A copy of any objections and 
hearing requests filed with the Hearing Clerk identified by the docket 
control number, [OPP-300641], must also be submitted to: Public 
Information and Records Integrity Branch, Information Resources and 
Services Division (7502C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington, DC 20460. In person, 
bring a copy of objections and hearing requests to Rm. 119, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA.
    A copy of objections and hearing requests filed with the Hearing 
Clerk may also be submitted electronically by sending electronic mail 
(e-mail) to: [e-mail]. Copies of objections and 
hearing requests must be submitted as an ASCII file avoiding the use of 
special characters and any form of encryption. Copies of objections and 
hearing requests will also be accepted on disks in WordPerfect 5.1/6.1 
file format or ASCII file format. All copies of objections and hearing 
requests in electronic form must be identified by the docket control 
number [OPP-300641]. No Confidential Business Information (CBI) should 
be submitted through e-mail. Electronic copies of objections and 
hearing requests on this rule may be filed online at many Federal 
Depository Libraries.

FOR FURTHER INFORMATION CONTACT: By mail: Andrew Ertman, Registration 
Division (7505C), Office of Pesticide Programs, Environmental 
Protection Agency, 401 M St., SW., Washington,

[[Page 23391]]

DC 20460. Office location and telephone number: Rm. 278, CM #2, 1921 
Jefferson Davis Hwy., Arlington, VA 22202, [phone]; e-mail: 
[e-mail].

SUPPLEMENTARY INFORMATION: EPA issued a final rule, published in the 
Federal Register of July 2, 1997 (62 FR 35683) (FRL-5719-9), which 
announced that on its own initiative and under section 408(e) of the 
Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(e) and 
(l)(6), it established a time-limited tolerance for the residues of 
tebufenozide and its metabolites in or on apples at 1.0 part per 
million (ppm); apple pomace at 2.0 ppm; milk at 0.05 ppm; cattle sheep 
and goat meat at 0.02 ppm, fat at 0.10, kidney at 0.02 ppm, liver at 
1.0 ppm and meat byproducts at 0.10 ppm; and horse meat at 0.02 ppm, 
with an expiration date of June 30, 1998. EPA established the tolerance 
because section 408(l)(6) of the FFDCA requires EPA to establish a 
time-limited tolerance or exemption from the requirement for a 
tolerance for pesticide chemical residues in food that will result from 
the use of a pesticide under an emergency exemption granted by EPA 
under section 18 of FIFRA. Such tolerances can be established without 
providing notice or period for public comment.
    EPA received a request to extend the use of tebufenozide on apples 
for this year growing season due to the persistence of the tufted apple 
budmoth (TABM) (the primary fruit-feeding pest of apples in 
Pennsylvania, West Virginia, Virginia, Maryland and New Jersey) and the 
oblique banded leafroller (the primary fruit-feeding pest of apples in 
New York, Michigan, Ohio and southern Ontario and Quebec, Canada). The 
applicants indicated that TABM and OBLR are serious, fruit damaging 
pests due to their ability to develop resistance to currently 
registered insecticides. Apple growers and processors are experiencing 
losses from these pests due to quality downgrading and storage 
deterioration. It is anticipated that significant economic losses will 
occur this year based on the continuing trend of loss of efficacy of 
registered insecticides over the past several years. After having 
reviewed the submission, EPA concurs that emergency conditions exist 
for this state. EPA has authorized under FIFRA section 18 the use of 
tebufenozide on apples for control of the tufted apple budmoth and the 
oblique banded leafroller in Maryland, Michigan, New Jersey, New York, 
Pennsylvania, Virginia, and West Virginia.
    EPA assessed the potential risks presented by residues of 
tebufenozide in or on apples; apple pomace; milk; cattle, sheep, and 
goat meat, fat, kidney, liver, and meat byproducts; and horse meat. In 
doing so, EPA considered the new safety standard in FFDCA section 
408(b)(2), and decided that the necessary tolerance under FFDCA section 
408(l)(6) would be consistent with the new safety standard and with 
FIFRA section 18. The data and other relevant material have been 
evaluated and discussed in the final rule of July 2, 1997 (FRL-5719-9). 
Based on that data and information considered, the Agency reaffirms 
that extension of the time-limited tolerance will continue to meet the 
requirements of section 408(l)(6). Therefore, the time-limited 
tolerances are extended for an additional 18 month period. Although 
these tolerances will expire and are revoked on December 30, 1999, 
under FFDCA section 408(l)(5), residues of the pesticide not in excess 
of the amounts specified in the tolerances remaining in or on apples, 
apple pomace, milk, meat, meat fat, kidney, liver, and meat byproducts 
of cattle, sheep, and goats or horse meat after that date will not be 
unlawful, provided the pesticide is applied in a manner that was lawful 
under FIFRA and the application occurred prior to the revocation of the 
tolerances. EPA will take action to revoke these tolerances earlier if 
any experience with, scientific data on, or other relevant information 
on this pesticide indicate that the residues are not safe.

I. Objections and Hearing Requests

     The new FFDCA section 408(g) provides essentially the same process 
for persons to ``object'' to a tolerance regulation issued by EPA under 
new section 408(e) and (l)(6) as was provided in the old section 408 
and in section 409. However, the period for filing objections is 60 
days, rather than 30 days. EPA currently has procedural regulations 
which govern the submission of objections and hearing requests. These 
regulations will require some modification to reflect the new law. 
However, until those modifications can be made, EPA will continue to 
use those procedural regulations with appropriate adjustments to 
reflect the new law.
    Any person may, by June 29, 1998, file written objections to any 
aspect of this regulation and may also request a hearing on those 
objections. Objections and hearing requests must be filed with the 
Hearing Clerk, at the address given above (40 CFR 178.20). A copy of 
the objections and/or hearing requests filed with the Hearing Clerk 
should be submitted to the OPP docket for this rulemaking. The 
objections submitted must specify the provisions of the regulation 
deemed objectionable and the grounds for the objections (40 CFR 
178.25). Each objection must be accompanied by the fee prescribed by 40 
CFR 180.33(i). If a hearing is requested, the objections must include a 
statement of the factual issues on which a hearing is requested, the 
requestor's contentions on such issues, and a summary of any evidence 
relied upon by the requestor (40 CFR 178.27). A request for a hearing 
will be granted if the Administrator determines that the material 
submitted shows the following: There is genuine and substantial issue 
of fact; there is a reasonable possibility that available evidence 
identified by the requestor would, if established, resolve one or more 
of such issues in favor of the requestor, taking into account 
uncontested claims or facts to the contrary; and resolution of the 
factual issues in the manner sought by the requestor would be adequate 
to justify the action requested (40 CFR 178.32). Information submitted 
in connection with an objection or hearing request may be claimed 
confidential by marking any part or all of that information as CBI. 
Information so marked will not be disclosed except in accordance with 
procedures set forth in 40 CFR part 2. A copy of the information that 
does not contain CBI must be submitted for inclusion in the public 
record. Information not marked confidential may be disclosed publicly 
by EPA without prior notice.

II. Public Record and Electronic Submissions

    The official record for this rulemaking, as well as the public 
version, as described above will be kept in paper form. Accordingly, 
EPA will transfer any copies of objections and hearing requests 
received electronically into printed, paper form as they are received 
and will place the paper copies in the official rulemaking record which 
will also include all comments submitted directly in writing. The 
official rulemaking record is the paper record maintained at the 
Virginia address in ``ADDRESSES'' at the beginning of this document.
    Electronic comments may be sent directly to EPA at:
[e-mail].


    Electronic objections and hearing requests must be submitted as an 
ASCII file avoiding the use of special characters and any form of 
encryption. Objections and hearing requests will

[[Page 23392]]

also be accepted on disks in WordPerfect 5.1/6.1 or ASCII file format. 
All copies of objections and hearing requests in electronic form must 
be identified by the docket control number OPP-300629. No CBI should be 
submitted through e-mail. Electronic copies of objections and hearing 
requests on this rule may be filed online at many Federal Depository 
Libraries.

III. Regulatory Assessment Requirements

    This final rule extends a time-limited tolerance that was 
previously extended by EPA under FFDCA section 408(d) in response to a 
petition submitted to the Agency. The Office of Management and Budget 
(OMB) has exempted these types of actions from review under Executive 
Order 12866, entitled Regulatory Planning and Review (58 FR 51735, 
October 4, 1993). In addition, this final rule does not contain any 
information collections subject to OMB approval under the Paperwork 
Reduction Act (PRA), 44 U.S.C. 3501 et seq., or impose any enforceable 
duty or contain any unfunded mandate as described under Title II of the 
Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4). Nor does 
it require any prior consultation as specified by Executive Order 
12875, entitled Enhancing the Intergovernmental Partnership (58 FR 
58093, October 28, 1993), or special considerations asrequired by 
Executive Order 12898, entitled Federal Actions to Address 
Environmental Justice in Minority Populations and Low-Income 
Populations (59 FR 7629, February 16, 1994), or require OMB review in 
accordance with Executive Order 13045, entitled Protection of Children 
from Environmental Health Risks and Safety Risks (62 FR 19885, April 
23, 1997).
    Since this extension of an existing time-limited tolerance does not 
require the issuance of a proposed rule, the requirements of the 
Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply. 
Nevertheless, the Agency has previously assessed whether establishing 
tolerances, exemptions from tolerances, raising tolerance levels or 
expanding exemptions might adversely impact small entities and 
concluded, as a generic matter, that there is no adverse economic 
impact. The factual basis for the Agency's generic certification for 
tolerance actions published on May 4, 1981 (46 FR 24950), and was 
provided to the Chief Counsel for Advocacy of the Small Business 
Administration.

IV. Submission to Congress and the Comptroller General

    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the 
Small Business Regulatory Enforcement Fairness Act of 1996, generally 
provides that before a rule may take effect, the Agency promulgating 
the rule must submit a rule report, which includes a copy of the rule, 
to each House of the Congress and to the Comptroller General of the 
United States. EPA will submit a report containing this rule and other 
required information to the U.S. Senate, the U.S. House of 
Representatives, and the Comptroller General of the United States prior 
to publication of this rule in the Federal Register. This rule is not a 
``major rule'' as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: April 17, 1998

James Jones,

Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR Chapter I is amended as follows:

PART 180 -- [AMENDED]

    1. The authority citation for part 180 continues to read as 
follows:
    Authority: 21 U.S.C. 346a and 371.
    2. In Sec. 180.482, by amending paragraph (b) by changing the date 
for apples; apple pomace; milk; cattle, meat; cattle, fat; cattle, 
kidney; cattle, liver; cattle, meat byproducts; sheep, meat; sheep, 
fat; sheep, kidney; sheep, liver; sheep, meat byproducts; goats, meat; 
goats, fat; goats, kidney; goats, liver; goats, meat byproducts; and 
horses, meat from ``6/30/98'' to read ``12/30/99''.

[FR Doc. 98-11271 Filed 4-28-98; 8:45 am]
BILLING CODE 6560-50-F